scholarly journals THU0185 The value of adalimumab trough levels and clinical assessments in predicting clinical response in patients with established rheumatoid arthritis and an inadequate response to methotrexate

2018 ◽  
Author(s):  
J. Smolen ◽  
N. Mostafa ◽  
X. Huang ◽  
P. Noertersheuser ◽  
B. Kluender ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Response ◽  
Inadequate Response ◽  
Established Rheumatoid Arthritis ◽  
Clinical Assessments ◽  
Trough Levels

Golimumab trough levels, antidrug antibodies and clinical response in patients with rheumatoid arthritis treated in daily clinical practice

2014 ◽  
Vol 73 (12) ◽  
pp. 2217-2219 ◽  
Author(s):  
Eva L Kneepkens ◽  
Chamaida Plasencia ◽  
Charlotte LM Krieckaert ◽  
Dora Pascual-Salcedo ◽  
Desiree van der Kleij ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Practice ◽  
Clinical Response ◽  
Daily Clinical Practice ◽  
Antidrug Antibodies ◽  
Trough Levels

scholarly journals Monitoring Drug and Antidrug Levels: A Rational Approach in Rheumatoid Arthritis Patients Treated with Biologic Agents Who Experience Inadequate Response While Being on a Stable Biologic Treatment

2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Diana Mazilu ◽  
Daniela Opriş ◽  
Cecilia Gainaru ◽  
Mihaela Iliuta ◽  
Natalia Apetrei ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Response ◽  
Drug Level ◽  
Biologic Agents ◽  
Rational Approach ◽  
Inadequate Response ◽  
Das28 Score ◽  
Eular Response ◽  
Biologic Treatment ◽  
Serum Drug Level

Clinical response in patients with rheumatoid arthritis (RA) treated with biologic agents can be influenced by their pharmacokinetics and immunogenicity. The present study evaluated the concordance between serum drug and antidrug levels as well as the clinical response in RA patients treated with biological agents who experience their first disease exacerbation while being on a stable biologic treatment. 154 RA patients treated with rituximab (RTX), infliximab (IFX), adalimumab (ADL), or etanercept (ETN) were included. DAS28, SDAI, and EULAR response were assessed at baseline and reevaluated at precise time intervals. At the time of their first sign of inadequate response, patients were tested for both serum drug level and antidrug antibodies level. At the next reevaluation, patients retreated with RTX that had detectable drug level had a better EULAR response (P=0.038) with lower DAS28 and SDAI scores (P=0.01andP=0.03). The same tendency was observed in patients treated with IFX and ETN regarding EULAR response (P=0.002andP=0.023), DAS28 score (P=0.002andP=0.003), and SDAI score (P=0.001andP=0.026). Detectable biologic drug levels correlated with a better clinical response in patients experiencing their first RA inadequate response while being on a stable biologic treatment with RTX, IFX, and ETN.

scholarly journals Efficacy and safety of jakinibs in rheumatoid arthritis: A systematic review and meta-analysis

2020 ◽  
Author(s):  
Yufeng Yin ◽  
Mengru Liu ◽  
Xin Chang ◽  
Michun He ◽  
Mingjun Wang ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Clinical Response ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Inadequate Response ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Increased Risk ◽  
Serious Infections

Abstract Objectives To assess the efficacy and safety of jakinibs for the treatment of active rheumatoid arthritis (RA) in patients with an inadequate response or intolerance to conventional synthetic or biologic disease-modifying antirheumatic drugs (DMARDs). Methods A systematic search was conducted in PubMed, Embase and the Cochrane Library. Randomized placebo-controlled trials (RCTs) of jakinibs in RA patients were eligible. The effective outcome was RA improvement to reach an American College of Rheumatology 20%/50%/70% (ACR20/50/70) response rate at week 12 and 24 after treatment. The safety outcomes included treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), discontinuations due to adverse events, infections and serious infections. Results Twenty-eight randomized, double-blind, controlled trials including 14500 patients were included. Both at week 12 and 24, the pooled analysis was suggestive of an effective treatment with jakinibs, represented as the increased clinical response of ACR20, ACR50 and ACR70. The subgroup analysis based on different types of jakinibs demonstrated that only peficitinib treatment had no impact on the clinical response of ACR50 or ACR70 at week 12. Jakinibs were associated with an increased incidence of infections at week 12 and TEAEs and infections at week 24. No increase in the risk of SAEs, discontinuations due to adverse events, or serious infections was observed in comparisons between treatment with jakinibs and treatment with placebo in these patients. Conclusions Jakinibs are efficacious and well tolerated in RA patients up to a period of 24 weeks, although they are associated with an increased risk of infectious complications.

scholarly journals FRI0102 SERUM TNFΑ LEVELS AT 24 HOURS AFTER FIRST ADMINISTRATION OF CERTOLIZUMAB PEGOL PREDICT EFFECTIVENESS AT WEEK 12 IN PATIENTS WITH RHEUMATOID ARTHRITIS FROM TSUBAME STUDY (UMIN ID:0002381)

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 630.1-630
Author(s):  
Y. Miyazaki ◽  
K. Nakano ◽  
S. Nakayamada ◽  
S. Kubo ◽  
S. Iwata ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Response ◽  
Remission Rate ◽  
Certolizumab Pegol ◽  
Univariate Analysis ◽  
Inadequate Response ◽  
Clinical Effects ◽  
Tnf Inhibitor ◽  
Research Support ◽  
Low Serum

Background:To increase the remission rate of rheumatoid arthritis (RA), it is necessary to determine the efficacy of the tumor necrosis factor (TNF) inhibitor as early as possible. Moreover, the response to certolizumab pegol (CZP) at 12 weeks has been reported to predict its long-term efficacy.Objectives:As part of a prospective single-center observational study (TSUBAME study), we prospectively enrolled patients to be treated with CZP in our institution to evaluate its effectiveness and safety starting at 24 hours after the first dose in clinical settings, while recording blood CZP concentrations and biomarkers over time to examine their correlation with clinical effects.Methods:One hundred patients with RA and inadequate response to MTX who received CZP were enrolled in the TSUBAME study. The changes in serum TNFα, IL-6, and CZP levels at 24 hours after first administration of CZP were measured, and the correlation between serum biomarkers and clinical response was determined.Results:At 24 hours after CZP initiation, significant improvement was observed in the disease activity (baseline and 24 h: 5.4 ± 1.3, 5.0 ± 1.3, respectively, p < 0.01), which was maintained until week 12. (baseline and 12 w: 5.4 ± 1.3, 3.3 ± 1.4, respectively, p < 0.01). Serum TNFα and IL-6 levels significantly decreased at 24 hours after first administration of CZP compared to baseline. No correlation was found between TNFα and IL-6 levels at baseline and the clinical response. According to univariate analysis, low serum TNFα and IL-6 levels and high CZP levels at 24 hours were associated with DAS28 (ESR) remission at 12 weeks. According to multivariate analysis, low serum TNFα levels at 24 hours were significantly associated with DAS28 (ESR) remission at 12 weeks (OR 0.05, 95%CI 0.01, 0.75, p = 0.03). Based on these findings, an ROC curve was created using remission according to the DAS28 (ESR) at week 12 as a dependent variable and TNFα concentration at 24 hours as an independent variable, resulting in a cut-off value of 0.76 pg/ml. From this result, the TNFα concentration at 24 hours was divided into 2 groups according to this cut-off, and the rates of remission according to the DAS28 (ESR) at week 12 were compared. In the group with TNFα concentration at 24 hours below the cut-off value, the rate of remission according to the DAS28 (ESR) at week 12 was significantly higher than in the group with TNFα concentration at 24 hours above the cut-off value (below the cut-off: above the cut-off = 56.3%: 21.6%, p < 0.001). Between the group that achieved remission according to the DAS28(ESR) and the group that did not achieve remission at week 12, there was almost no difference in the distribution of TNFα concentrations at baseline; however, the distribution of TNFα concentrations at 24 hours was lower in the group that achieved remission.Conclusion:CZP was effective where serum TNFα was strongly neutralized within 24 hours. These results suggest that low serum TNFα levels at 24 hours after first administration of CZP may predict the effectiveness of CZP. To increase the remission rate in RA, it is necessary to determine the effectiveness of the molecular targeted drugs used at an early point, in addition to how rapid the onset of action is. CZP is extremely fast-acting, and its effectiveness can be predicted as early as 24 hours after the first dose, suggesting that it may be possible to determine the effectiveness early.Acknowledgments:The authors thank Ms. M. Hirahara for providing excellent technical assistance.Disclosure of Interests:Yusuke Miyazaki Grant/research support from: Astellas Pharma Inc and UCB S.A., Kazuhisa Nakano: None declared, Shingo Nakayamada Grant/research support from: Mitsubishi-Tanabe, Takeda, Novartis and MSD, Speakers bureau: Bristol-Myers, Sanofi, Abbvie, Eisai, Eli Lilly, Chugai, Asahi-kasei and Pfizer, Satoshi Kubo: None declared, Shigeru Iwata: None declared, Kentaro Hanami: None declared, Shunsuke Fukuyo: None declared, Ippei Miyagawa: None declared, Ayako Yamaguchi: None declared, Akio Kawabe: None declared, SAITO KAZUYOSHI: None declared, Yoshiya Tanaka Grant/research support from: Asahi-kasei, Astellas, Mitsubishi-Tanabe, Chugai, Takeda, Sanofi, Bristol-Myers, UCB, Daiichi-Sankyo, Eisai, Pfizer, and Ono, Consultant of: Abbvie, Astellas, Bristol-Myers Squibb, Eli Lilly, Pfizer, Speakers bureau: Daiichi-Sankyo, Astellas, Chugai, Eli Lilly, Pfizer, AbbVie, YL Biologics, Bristol-Myers, Takeda, Mitsubishi-Tanabe, Novartis, Eisai, Janssen, Sanofi, UCB, and Teijin

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